Should Alzheimer’s drugs be treated like all other drugs when it comes to Medicare coverage? The Alliance for Aging Research CEO Sue Peschin and BrainStorm host Meryl Comer dive into polling data that reveals most American voters, regardless of party, disagree with CMS’s policy that will limit access. Their conversation sheds light on how the coverage decision, if it stands, will create not only greater disparities, but also have wide-ranging implications on coverage for other disease-modifying therapies.
This episode is sponsored by Eisai.
Should Alzheimer’s drugs be treated like all other drugs when it comes to Medicare coverage? The Alliance for Aging Research CEO Sue Peschin and BrainStorm host Meryl Comer dive into polling data that reveals most American voters, regardless of party, disagree with CMS’s policy that will limit access. Their conversation sheds light on how the coverage decision, if it stands, will create not only greater disparities, but also have wide-ranging implications on coverage for other disease-modifying therapies.
This episode is sponsored by Eisai.
Sue Pechin (00:01):
This is really cuts at the heart of, I would say, the political future of the country. That's how strongly people feel about this issue. We really should be about caring for each other, right? We shouldn't be picking one issue over another. So where is the care for people with early Alzheimer's disease? That's what our question is to him. This is a moment where he can rise. He can be a hero, he can step in. He has a C M S that's run amok and it's time to intervene.
Opening (00:33):
Welcome to BrainStorm by UsAgainstAlzheimer's, a patient-centered nonprofit organization. Your host, Meryl Comer, is a co-founder, 24 year caregiver and Emmy award-winning journalist and the author of the New York Times bestseller, slow Dancing With a Stranger.
Speaker 1 - Meryl Comer (00:51):
This is BrainStorm and I Meryl Comer. The Alliance for Aging Research tagline reads “unprecedented challenges, unwavering optimism to create a healthier, dignified aging experience for all". Joining us is its President and CEO, Sue Peschin. Sue, thank you for joining us.
Speaker 2 – Sue Peschin (01:11):
Great to be here.
Speaker 1 - Meryl Comer (01:11):
When we talk about aging research, how is it defined?
Speaker 2 – Sue Peschin (01:15):
Well, we look at aging from the moment that we're born, so we really look at aging across the lifespan. When we talk about healthy aging, we typically are focused on people from either right pre-Medicare in their fifties to 65 and older, which is the Medicare population. But we should all be focused on healthy aging throughout the lifespan.
Speaker 1 - Meryl Comer (01:39):
So have attitudes about aging changed since the 65 plus crowd is fast becoming the new majority and at what age is considered old today?
Speaker 2 – Sue Peschin (01:48):
I don't think, unfortunately, attitudes have changed all that much about aging. I think ageism reached a new level during Covid-19. Unfortunately, the older adult population was ravaged during the Covid-19 pandemic, and there was a lot of conversation around prioritization. We were talking about who do you give the ventilators to first? And age definitely came up as a consideration there. And so I think that there's a lot of work that we need to do around how we value people, how we value innovation in healthcare, because traditional health economics really does ding people when they're no longer considered productive in society, which is typically when we retire. And so innovations that are meant for people as they age, which is when you're more likely to develop chronic conditions like Alzheimer's or other types of common diseases. They're not considered as valuable to society. So that's a problem as well. But from our perspective, we need to really recognize that it's worth the investment that when you contribute your entire life to programs like Medicare, you pay taxes into the program your entire life. You don't expect it to be cherrypicked as you get older. And you get to that point that when you need healthcare, when you need a new innovation, it should be there for you. It should be available to you just like it is for all other types of disease areas.
Speaker 1 - Meryl Comer (03:20):
The Alliance has been around for more than three decades, and you've worked on some of the most complex and stigmatized health equity issues. You've mentioned the health ageism. How pervasive is it across institutions? You mentioned the care system, but the health institutions in general.
Speaker 2 – Sue Peschin (03:38):
I think a lot of it does start with how we value. And so health economics inherently is discriminatory towards older adults because we put a lot of value on length of life as opposed to quality. And even though health economics purports to consider quality, there is much more emphasis on how much a particular innovation extends our lives. So if you have less of life to live that's in front of you, then inherently you're not as valuable. And that's really where it starts. So from anywhere from where we are in the clinician setting to the types of services that we think about around the care system, it's all geared towards younger, healthier people.
Speaker 1 - Meryl Comer (04:26):
Let's move to an issue that is critical for both organizations. We have an estimated 2000 Americans who progress from mild to moderate disease every day. And just last month, the Food and Drug Administration (FDA) Advisory Committee endorsed the traditional approval of Lecanemab for early stage Alzheimer's. In your opinion, how egregious is CMS’s refusal to cover FDA approved early Alzheimer's therapies compared to medications for all other diseases?
Speaker 2 – Sue Peschin (04:58):
How egregious? Incredibly egregious. You're looking for a qualification there, and it is pretty unprecedented what they (CMS) have done. They made a decision in April of last year, in 2022, and it really hasn't changed. If anything, they've doubled down on that decision to say that when drugs are approved either through accelerated approval, which was something that was given to the FDA to determine back in the 80s around the HIV/AIDS epidemic and has only been expanded since then for diseases that are life-threatening rare. Or in cases where patients either have run out of options or didn't have any options to begin with. So accelerated approval is approval according to Congress and under the FDA's regulatory authority. But CMS has put that into question as they have also put traditional approval into question. And now we have this class of therapies for Alzheimer's disease that starting last year was determined just based on one therapy for an entire class, even before they had data on any of the other therapies that is attacking both accelerated approval and traditional approval.
Speaker 2 – Sue Peschin (06:14):
And as you said, an advisory committee to the FDA determined that the second therapy that's now come along should be considered for traditional approval. We're probably going to be seeing the FDA follow through on that recommendation from their advisory committee, which was unanimous, six to zero recommended traditional approval. The FDA has to decide by July 6th, and everyone is expecting in the community that the FDA will follow its advisory committee recommendation and give it traditional approval. But what we are facing is Centers for Medicare and Medicaid Services (CMS), which is the federal agency that oversees the Medicare program, not ready to provide coverage and reimbursement for that traditional approval. They have coverage on paper, but they are using a special tool called coverage with evidence development that is essentially a tool that's used to ration that type of care, where they look at therapies that either impact a large population of folks, which is what you're looking at with Alzheimer's, even though we're just talking about mild cognitive impairment and early dementia due to Alzheimer's disease.
Speaker 2 – Sue Peschin (07:23):
So it's not the entire population, but it's still a large number of people or for therapies where they think it's cost prohibitive in some way. And in this case, it's really cost prohibitive just based on the number of people that would utilize the therapy. And they're saying, no, we don't have room for it. We don't want to cover and reimburse it. And what they're doing with it is they're opening up a Pandora's box to not just use it for this class of therapies, but to use it for future ones in rare disease in gene therapy, other types of breakthrough therapies where folks have no options right now and apply this same paradigm. It's incredibly egregious.
Speaker 1 - Meryl Comer (08:03):
It's also precedent setting then for these other diseases as well. I mean, we both have lived in the Alzheimer's space with loved ones, Sue. We know that time is of the essence, especially we are trying to slow disease progression. That's all we have. And that denial becomes just heartbreaking, I think, for so many families. But it also is an equity issue. It cuts off access for the vast majorities of beneficiaries living with early disease, except those who can afford to pay for it out of pocket, and it all becomes too expensive. They don't reimburse. They don't even reimburse for long-term chronic care.
Speaker 2 – Sue Peschin (08:44):
And you're absolutely right, Meryl. I mean, you hit the nail on the head that this cuts to the heart of equity. And CMS says that that's one of their pillars. That's a core value for them, but they're certainly not showing it with this restrictive policy. And what's at play here is African Americans are at two times the risk of developing Alzheimer's, and Latinos are at one and a half times the risk. So folks who are more dependent on that coverage and reimbursement through Medicare are going to be the hardest hit with this type of a policy. And that's because the coverage with evidence development requirement requires these extra clinical studies over and above what the FDA is already required the manufacturer to show for safety and effectiveness. And these types of studies are ones that are more likely to only be resourced at large academic centers in wealthier areas of the country. So rural communities will be shut out and lower income communities of color in urban areas will be shut out.
Speaker 1 - Meryl Comer (09:51):
You're also creating a regulatory fight between agencies where the MS is challenging the authority of the FDA, which is unprecedented as well.
Speaker 2 – Sue Peschin (10:02):
That's right. I mean, we spoke up at the recent advisory committee meeting at the FDA, and I think the main issue that we wanted to bring up is, you know, we're in this era of misinformation and disinformation and we really feel like CMS is contributing to that. They're giving this impression that the FDA is not fully equipped to determine the safety and efficacy of this class of therapies. And that CMS needs to be this second check on the system, even though they are not a biomedical agency. The way the FDA is, CMS is a payer. That's all they are. They have no neurologist there. They have nowhere near the expertise of the FDA, but they are creating that misinformation loop when it comes to this class of therapies. And that's just not right. They're contributing to something that they are supposed to be fighting against.
Speaker 1 - Meryl Comer (10:56):
So let's put the efficacy community and action when they work the Alliance in partnership with the LEAD Coalition, the Global Alzheimer's Platform Foundation, and UsAgainstAlzheimer's commissioned this bipartisan polling. I mean, we're coming into an election cycle to learn how the American voters feel about CMS’s refusal. What were the top line findings? Any surprises? You walk us through it.
Speaker 2 – Sue Peschin (11:21):
Absolutely. I mean, I think one of the things that both Lake Research Partners and Public Opinion Strategies, which were the partisan, the Democrats with Lake Research Partners and the Republicans with the Public Opinion Strategies found, was that these numbers were so strong no matter how they asked these questions. This amounted to a core issue for the American people, the voting public,. These numbers were in the eighties to nineties in terms of them getting that they're creating this exception at CMS and voters just don't think that's fair. Over 80% want either Congress or the President to step in if CMS does not change this restrictive policy because they think that without a doubt, if the FDA has approved this as safe and effective therapies, that CMS and the Medicare program should absolutely cover it. And there should not be an exception for Alzheimer's as there should be the same process as coverage is guaranteed for FDA-approved therapies in other disease areas just like we do for any other disease. So that's pretty much what the poll found. One of the things that I think was most striking, and I love this statistic, is you know, they looked at Biden voters; 2020 Biden voters and 2020 Trump voters. 52% of Trump voters want this president that they didn't vote for and theoretically can't stand to step in and change. This policy of CMS doesn't take the initiative to do it themselves. And that says a lot to me.
Speaker 1 - Meryl Comer (12:59):
It also says that Alzheimer's is personal for so many Americans, you know, more than half know someone or they're caring for a loved one. It is so pervasive now and it's top of mind for anyone 65 plus. In fact, the numbers are running higher for fear of the disease against cancer or heart disease and some others as well. You have also stated that it's completely inappropriate for CMS to insert itself between patients with early Alzheimer's and their doctors, but that's exactly what they're doing. Can you explain that a little more?
Speaker 2 – Sue Peschin (13:35):
Absolutely. I mean, CMS says that they don't interfere in clinical decision making, but that is what's happening here. You're taking out the benefit risk conversation between clinicians and their patients. It's incredibly ageist. It's paternalistic towards people with Alzheimer's related dementias. That conversation can't occur between clinicians and patients who often, as you know, Meryl very well come with their family caregivers. So it's also a conversation for the entire family and they are inserting themselves and not allowing those conversations to happen. You have FDA approved therapies, so they have determined these therapies are safe and effective. And then the next step in that conversation needs to happen between clinicians and the people living with the disease along with their family caregivers. CMS does not belong in the middle of that conversation.
Speaker 1 - Meryl Comer (14:30):
Is CMS also sort of testing the water to see whether they can prioritize financial risk over health risk?
Speaker 2 – Sue Peschin (14:37):
That's right. They are doing that and that is not what they are charged with doing. They were given the responsibility simply to manage the Medicare program for all of us as Americans who pay into this system for the majority of our lives and throughout our working lives. And then to simply administer this program, not to cherry pick and say, we're going to cover this area in cancer or in HIV/AIDS, but we're going to make an exception for Alzheimer's disease. That's not their job. It's not their authority. It's not what Congress gave them the ability to do. They claim that they get to pick based on reasonable and necessary in the Medicare program where the FDA does safe and effective, but they've never fully defined what's meant by reasonable and necessary other than they respect the FDA's authority when the FDA determines something is safe and effective. So they've done that here, so they should cover it all.
Speaker 1 - Meryl Comer (15:36):
The top line, as I understand it, results in your surveys for race, gender, political party were combined. Is that correct?
Speaker 2 – Sue Peschin (15:45):
Yes, absolutely. And when they were fully combined, you get all the way up to 90%, which makes this a core issue. I'll tell you something, it polls a lot higher than religion even than tolerance for others. And that's saying something. So this is an easy issue as far as President Biden goes, as far as members of Congress on both sides of the aisle. Go. Everybody should come together on this.
Speaker 1 - Meryl Comer (16:08):
So let's get political. 4 in 10 voters have a family member that have had Alzheimer's one quarter say they're caring for someone with the disease. I think UsAgainstAlzheimer's chair, George Vradenburg said, this is more than a margin of victory in swing states. What is the next battle ground and what do you say to members of the alliance? What's at stake going forward?
Speaker 2 – Sue Peschin (16:32):
This is really cuts at the heart of, I would say, the political future of the country. That's how strongly people feel about this issue. We really should be about caring for each other, right? We shouldn't be picking one issue over another. This president has started Cancer Moonshot, and at the same time, he's also promised not to cut benefits in the Medicare program. So where is the care for people with early Alzheimer's disease? That's what our question is to him. This is a moment where he can rise, he can be a hero, he can step in. He has a CMS that's run amok and it's time to intervene.
Speaker 1 - Meryl Comer (17:09):
And what do you say to voters?
Speaker 2 – Sue Peschin (17:11):
I say to voters, speak up. Let your members of Congress know that this is an issue that matters to you. Make it matter when you go to the polls. And I think that it's going to make a difference in, in terms of competitors. People should see it as an opportunity to speak out on behalf of people who need it the most. Family caregivers. This is something that affects all of us across the board. So let it be known and let the best spokes win.
Speaker 1 - Meryl Comer (17:38):
Well, Sue, thank you for leading the fight. Our guest has been Sue Peschin, President and CEO of the Alliance on Aging Research. That's it for this edition. I'm Meryl Comer. Thank you for brainstorming with us. Our team is on a mission to help you stay up with the latest scientific breakthroughs from new therapies to technologies on early diagnosis and personal brain health advice from well-known experts using an equity lens that promotes brain health for all. Now, we'd like to hear what's on your mind, what are the topics and guests you'd like to hear featured on BrainStorm? Send your comments to brainstorm@usagainstalzheimers.org
Closing (18:22):
Support for BrainStorm by UsAgainstAlzheimer's comes from Eisai. For four decades, Eisai commitment to Alzheimer's disease has never wavered, even when faced with complexities and challenges that caused others to relinquish pursuit. Eisai has never given up on developing therapeutic and ecosystem solutions for people and families living with Alzheimer's and other neurogenerative diseases.
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